Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05736705 |
| Other study ID # |
H-52921 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 31, 2024 |
| Est. completion date |
October 31, 2024 |
Study information
| Verified date |
January 2024 |
| Source |
Baylor College of Medicine |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The objective of this study is to prospectively document the efficacy and clinical outcomes
of Endoscopic Submucosal Dissection procedure that utilize either a novel Bipolar-Current ESD
device or the standard monopolar electrocautery knife.
Description:
Endoscopic submucosal dissection (ESD) is a novel technique for the removal of esophageal
lesions or polyps with high-risk features. ESD is minimally invasive and allows the removal
of esophageal polyps without resorting to morbid surgery. The process of ESD includes marking
the lesions selected for removal, followed by submucosal injection of a lifting agent, then
circumferential incisions using a specialized knife followed by submucosal dissection of the
entire lesion.
Traditionally, knifes utilizing monopolar current such as dual knife or hybrid knife were the
preferred tools for endoscopic submucosal dissection. These knifes allows accurate dissection
and excellent hemostasis. However, due to monopolar current generated heat, post coagulation
syndrome can be seen in up to 8 to 40 % of patients. Post coagulation syndrome present with
pain, fever and leukocytosis and requires supportive treatment with IV fluid and antibiotics.
In addition, for large esophageal lesions, stricturing can occur after resection due to
significant scar formation induced by large amounts of energy. Almost all patients with 60%
of the esophageal circumference removed via monopolar knives, will develop an esophageal
stricture at some point. These patients require serial esophageal dilations, and although
easily managed, its development can be quite troublesome to the patient. Nevertheless, ESD is
still the preferred modality for removal of these lesions, since it avoids the need for
morbid surgery. Recently, a novel bipolar RFA knife were approved by FDA for the performance
of ESD. The knife utilizes bipolar RFA current for submucosal dissection which can
potentially expedite submucosal dissection and decrease the rates of post polypectomy
syndrome and scar formation, by using significantly less energy. This bipolar knife may allow
for removal of large esophageal lesions without causing major esophageal stricturing.
Our tertiary referral center Baylor St Luke's Medical Center is a center of excellence for
ESD procedure and the investigators have previously reported our Esophageal ESD experience
using the monopolar current knife. The goal of our protocol is to compare the performance of
monopolar current cutting knife and bipolar RFA knife in esophageal endoscopic submucosal
dissection.
